This is the first Newsletter of the Anesthesia Patient
Safety Foundation, which was incorporated on September 30, 1985. The mission
of the APSF is clear and simple-to encourage activities that will prevent
patients from being harmed by the effects of anesthesia. Why such a foundation?
What activities shall it promote to fulfill its mission? What resources
will support those activities? What can you do to help?

It is generally agreed that anesthesia is safer than it
has ever been, but that it still isn't safe enough. In the United States,
annually some several thousand patients die or are seriously injured at
least in part by their anesthetic experience. Them is strong evidence that
more than half of these adverse outcomes are preventable by applying known
precepts of anesthesia management. Yet, the causes of preventable deaths
and injuries are diverse and complicated. There is no one evil and no simple
cure.

The first step toward improvement is creating awareness
that a problem exists. Education, training, application of current and
developing technologies and acquiring new knowledge about the causes and
prevention of mishaps are components of a solution matrix.

Anesthesia mortality is everybody's problem. Most people
will be exposed to the risk several times in their life. When a bad outcome
occurs, it affects not only the patient, but has a lasting impact on the
family, the anesthetist, and the anesthetist's colleagues as well. It is
also a problem for many other constituencies-the manufacturer and designer
of equipment that is involved or implicated in an accident and the hospital
administrator in whose operating room an accident occurred. For the companies
that provide liability insurance, there is the clear and present danger
that the malpractice crisis, caused at least in part by preventable injuries,
may severely damage or cripple the viability of their organizations. That
this crisis puts the entire health care system in jeopardy makes this a
problem for the federal government also.

Because there has been no place that these constituencies
can join forces to promote change, the Anesthesia Patient Safety Foundation
was formed. Its goals are:

*To foster investigations that will provide a better understanding
of preventable anesthetic injuries;

*To encourage programs that will reduce the number of
anesthetic injuries; and

*To promote national and international communication of
information and ideas about the causes and prevention of anesthetic injuries.

During the first year, the Foundation's aims are to start
a communication vehicle (this newsletter) and to establish a research fund,
awarding several grants. Committees have been created to implement these
activities.

Who is the APSF? Its 30 -member Board of Directors includes
representatives from anesthesiology, nurse anesthesia, device and pharmaceutical
manufacturing, the insurance industry, hospitals, biomedical engineering,
and the FDA (see page 5 of this newsletter for a complete list of the Board
and committees). Membership in the APSF is open to any individual contributing
at least $25 and any corporation contributing at least $500. Contributions
will go toward funding the cost of producing and distributing this newsletter
to the approximately 45,000 people who have a stake in preventing anesthesia
injuries and toward the support of safety-related research activities.

You won't have to be a member of the APSF to benefit from
its efforts but, yes, you will receive a certificate of membership if you
join. The real reason to contribute $25 or more is because you want to
make anesthesia safer. Because it can be. Because it should be. We think
that some improvements, through increasing awareness and through implementing
some new technologies, can be had in the short term-a few years. But, the
ultimate goal of near-absolutely injury-free anesthesia will take longer
because the impact of training, of education, and of innovative ideas derived
from research take time to percolate through a culture. But, it can be
done. We need your help.

WHAT MONRMRING did Dr. W.T.C. Morton use during the first
surgical operation under ether anesthesia October 16, 1846? (Also, what
were his malpractice insurance premiums?)

Groups Publish Conventions

Physicians and nurses who devote their work to the practice
of anesthesia have one common goal, namely to make anesthesia as safe for
their patients as humanly possible. Despite these efforts the occasional
disaster occurs and a patient suffers harm. Whenever this happens, an agonizing
search begins: what could have been done to prevent the problem.

Of all the many steps that have been recommended to make
anesthesia safe, few are universally accepted; indeed the measures urged
by some for adoption as essential safety precautions are considered by
others as being not all that helpful. For example, the esophageal (or precordial)
stethoscope has been praised as being a wonderful monitor. It requires
no electricity and is therefore immune to power outages and electrical
artifacts. It allows the anesthetist to listen without interruption to
heart sounds and breath sounds. Thus it becomes a monitor that alerts the
anesthetist to the cardiac standstill as well as the disconnected ventilator.
Indeed, it can help with more subtle diagnoses, such as the muffled cardiac
sounds of a depressed heart or the wheezes of bronchospasm.

How could anyone denigrate the esophageal or precordial
stethoscope? The critics love to recount stories in which the anesthetist
failed to notice that breath and heart sounds had suddenly disappeared
when the tube from chest to ear was furtively clamped. So what good is
a monitor that depends solely on the attention of a human being who can
be distracted or can become so inured to a monotonous sound that he no
longer notices when the sound vanishes?

Clinical examples

Let us ask if we can identify monitors American anesthetists
would agree on calling essential. Let us define as essential any monitor
that would cause us to cancel an elective case should neither the monitor
nor an equivalent be available. Let us also agree to focus on simple, short
anesthetics in healthy patients. For example, imagine a general anesthetic
needed for the placement of myringotomy tubes in a six year old boy, or
a saddle block in a healthy 20 year-old man in lithotomy position for a
hemorrhoidectomy.

A skilled anesthesiologist or anesthetist must be present
in the operating room. Beyond that the question becomes more difficult
to answer because now we have options. Those who insist on watching an
ECG monitor and recording the arterial blood pressure might be challenged
by others who say that a precordial stethoscope and a pulse oximeter could
adequately replace the ECG and blood pressure monitor in healthy, young
patients. Some might insist on monitoring the temperature, others would
be satisfied with having a thermometer available should clinical suspicion
call for a temperature measurement. Some insist on an oxygen analyzer in
the breathing circuit, others are prepared to omit one when they use a
Bain circuit. When the patient is awake, some believe that verbal communication
maintained with the patient is as good a monitor as any, because an alert
patient clearly demonstrates good cerebral perfusion and oxygenation. So
where should the line be drawn? Should it be left to the judgment of every
individual anesthetist?

Current Recommendations

While the majority of us still practice as we have been
taught and as our clinical experience dictates, others have formed groups
and in laborious discussions have developed monitoring conventions to which
they plan to adhere. There are, for instance, the "Guidelines for Patient
Care in Anesthesiology" developed and endorsed by the Arizona Society of
Anesthesiologists, dated February 23, 1985. These recommend for patients
undergoing general anesthesia:

1) Oxygen analyzer with low concentration alarm in the
circuit.

2) Low pressure alarm on the anesthesia ventilator if
used during the course of the anesthetic.

3) Two of the follou4ng three modalities.-

a) intermittent or continuous blood pressure monitoring

b) continuous electrocardiographic display

c) precordial esophageal stethoscope-

The Department of Anesthesia of the Harvard Medical School
adopted on March 25, 1985 and revised on July 3, 1985 its "Standards of
Practice 1; Minimal Monitoring" which include for preplanned anesthetics
administered in designated anesthetizing locations where not clinically
impractical.

Blood Pressure and Heart Rate

Every patient receiving general anesthesia, regional anesthesia,
or monitored intravenous anesthesia shall have arrival blood pressure and
heart rate measured at least every five minutes where not clinically impractical.

EKG

Every patient shall have the electrocardiogram continuously
displayed from the induction or institution of anesthesia until preparing
to leave the anesthetizing location, where not clinically impractical.

Continuous Monitoring

During every administration of general anesthesia, the
anesthetist shall employ methods of continuously monitoring the patient's
ventilation and circulation. The methods shall include, for ventilation
and circulation each, at least one of the following or the equivalent.

For ventilation-palpation or observation of the reservoir
breathing bag, auscultation of breath sounds, monitoring of respiratory
gases such as end-tidal CO, or monitoring expiratory flow.

When ventilation is controlled by an automatic mechanimi
ventilator, them shall be in continuous use a device that is capable of
detecting disconnection of any component of the breathing system. ne device
must give an audible signal when its alarm threshold is exceeded.

Oxygen Analyzer

During every administration of general anesthesia using
an anesthesia machine, the concentration of oxygen in the patient breathing
system will be measured by a functioning oxygen analyzer with a low concentration
limit alarm in use.

Ability to Measure Temperature

During every administration of general anesthesia there
shall be readily available a means to measure the patient's temperature.

More recently another group with representatives from
industry and anesthesia, the Anesthesia Safety Consortium, drafted a set
of recommendations designed to reduce the incidence of problems related
to inadequate oxygenation of patients. The monitors that were recommended
included:1) an in-circuit oxygen analyzer with low alarm2) capnography3) means for the measurement oft the patient's oxgenation4) means for the detection of undesirable airway pressure,
both high and low.

What will you do clinically?

Let us now return to our patients and ask again, what
monitors should we demand for our patients to have general anesthesia or
a saddle block? We can answer the question with assurance if we are willing
to embrace one or the other set of conventions. But which one? We will
search in vain for scientific evidence demonstrating that this or that
convention will indeed improve the lot of our average patient. Nevertheless,
such conventions prepared by recognized experts, published by widely respected
groups and obviously drawn up with the best of intentions of improving
the safety of anesthesia will assume a life of their own. Ignoring such
conventions will cause critics to ask whether applying those conventions
could possibly hurt and whether they might not indeed help? And once we
have to admit that they might, in fact, be helpful in reducing adverse
incidents in anesthesia, we have taken the first step toward adopting them
ourselves.

With the publication of these first conventions, we are
entering a new phase in anesthesia. Can we expect the formulation and adoption
of national conventions? It is too early to predict in detail the practices
and monitors that are going to be included in such a national effort. But
many assume that for the first time we will have minimal essentials that
will influence our practice.

On the one hand, we will see much more uniformity in the
practice of anesthesia. On the other, for the first time them will be occasions
when we will say, sorry, I have to delay this case until this monitor has
been repaired. Of course, there will have to be alternatives in emergencies
or in clinical circumstances where one or the other convention cannot be
met. But we will be expected to justify and document deviations from the
conventions.

It is a fair bet that the monitoring modalities mentioned
in the first guidelines published by the Arizona group, the standards of
the Harvard Department, and the recommendations of the Patient Safety Consortium
are going to come under close scrutiny for inclusion in any list of minimal
essentials. The Anesthesia Patient Safety Foundation will closely examine
proposed monitoring conventions and it will also tap the enormous clinical
experience represented by the thousands of anesthesiologists and nurse
anesthetists who practice in the United States. Therefore, the Foundation
needs to hear from you! Please write and tell us your ideas on how to make
anesthesia as safe as possible for the patients entrusted to our care.

The Anesthesia Patient Safety Foundation Grant Program
will support clinical research directed toward enhancing patient safety.
Its major objective is to stimulate studies leading to anesthesia methods
which will completely prevent anesthesia mishaps (also described as anesthesia
accidents, misadventures, critical incidents and morbidity).

The major interest is in studies which can be completed
within one year, those that concern problems of anesthesia for relatively
healthy patients, those that primarily utilize existing medical knowledge,
and those that promise improved methods of patient safety readily incorporated
into clinical practice.

Areas of research interest include, but are not limited
to, new clinical methods for prevention and/or early diagnosis of mishaps,
evaluation of new and/or reevaluation of old technologies for prevention
and diagnosis, and identification of predictors of patients and anesthetists
at increased risk for mishaps. Potential research areas also in crude development
of innovative methods for study of low frequency events as mishaps, particularly
in community hospitals, and methods for measurement of cost effectiveness
of techniques and equipment designed to increase patient safety.

Applications should be received no later than July 15,
1986. Requests should not exceed $35,000. Awards will be announced before
October 1, 1986 for projects to begin January 1987. Guidelines for application
for an APSF grant are available from:

Mr. Glenn W. Johnson

Administrator

Anesthesia Patient Safety Foundation

515 Busse Highway

Park Ridge, Illinois 60068

Dr Keats is Chief, Division of Cardiovascular Anesthesia
at the Texas Heart Institute, Houston, and Clinical Professor of anesthesiology,
University of Texas.

"The trouble is you haven't included the surgeons and
your data will be valueless." That's what they said about Mortality Associated
with Anesthesia before the report was published. But they were wrong. That
study showed how safe anesthesia is (one in 10,000 operations followed
by death wholly attributable to anesthesia) and that the few deaths were
often avoidable and usually attributable to human error.

Encouraged by the response to this study, the Association
of Anesthetists of Great Britain and Ireland sought and obtained funds
(from the Snuffled Provincial Hospital Trust and the King's Fund for Hospitals)
to support another large project which has recently started in the United
Kingdom. This unique study involves all surgical disciplines as well as
anesthesia and is a fully cooperative venture between the Association of
Anesthetists of Great Britain and Ireland and the Association of Surgeons
of Great Britain and Ireland. The aims of now the study are the same as
before: mortality rates(perhaps for a few specific operations as well as
to global rates), and to identify avoidable factors in that deaths which
occur in hospital within 30 days of operation.

More than 400 assessors have been appointed University
of Wales, in both disciplines. These experts will review all College of
Medicine, Cardiff the deaths about which there is any doubt and a random
sample of all other deaths. Their opinions will form the basis of the report
which will be published after the study has continued for 12 months. Three
Regions of the country have been selected (estimate 600,000 operations)
and every hospital (60) visited by two clinical coordinators (a surgeon,
H. B. Devlin) and an anesthetist (the writer). The response to this recruitment
drive has exceeded our expectations and a total of about 96% of the consultant
staff has agreed to cooperate; it is still a voluntary matter.

When a death occurs, each specialist completes a detailed
questionnaire designed to provide information about the management of the
case. These questionnaires are examined by the two clinical coordinators,
stripped of their identity, and then sent to the appropriate assessors.

Questionnaires are arriving at the office daily and in
the first six weeks of the project, over 1000 have been scrutinized. It
is no exaggeration to claim that British anesthetists and surgeons are
prepared to examine their own practice and expose it to peer review. We
have evidence this audit process is already provoking the most recalcitrant
to change and, we hope, to improve in practice.

At the Medical College of Virginia, Richmond, 27 cardiac
arrests Judged due solely to anesthesia occurred in 163,240 total anesthetics
over a fifteen-year period (1.7 per 10,000) causing fourteen deaths (0.9
per 10,000). Among the 27: six were under twelve years old, nineteen were
1265 years, and only two were over 65; also, ASA physical status classifications
were 1-two, 11-five, III-ten, IV-ten, (V not included). Note that Classes
I and 11 account for only seven arrests in 163,240 cases and only two deaths
(I /81,620). Cardiac arrest during emergency surgery was six times more
likely than during elective surgery. Of the 27 cases, nine had absolute
overdoses of inhalation agent and six relative overdoses of intravenous
agent. Twelve included inadequate ventilation: four difficult airway, four
esophageal intubations, two ventilator disconnects, and one each displaced
endotracheal tube and bronchospasm.

Judgments about the likely preventability of the accidents
were recorded. Among the 2 7 cases of cardiac arrests: 20 were "avoidable"
(eleven inadequate ventilation and nine inhalation overdoses), six were
"questionable" (the relative intravenous overdoses in hemodynamically unstable
patients three each cardiac and septic), and one was felt to be "unavoidable"
(intractable asthma). Thus, a specific anesthetic "error" was identified
in 75% (20 of 27) of the arrest cases. A strong point was made that progressive
bradycardia preceded the cardiac arrest in all but one of the cases. The
authors suggest that when there is unexplained bradycardia, increased ventilation
with 100% oxygen should automatically be the first response considered.
Drug idiosyncrasy, anaphylaxis, and succinylcholine induced hyperkalernia
were seen but did not cause arrest. Malignant hyperthemia was not seen.

Question Is monitoring for hypoxemia more important
than for hypercarbia?

Answer Hypercarbia is, by itself, a serious but
not usually life-threatening condition. If, however, hypoventillation leads
to hypoxia, respiratory and/ or cardiac arrest often follow.

Hypercarbia may result from increased C02 production relative
to C02 elimination (as in hyperthermia, emergence excitement, or excessive
caloric intake from hyperalimentation solutions) or from hypoventillation
due to incorrect ventilator settings, airway obstruction, depressed central
respiratory drive (from anesthetic overdose), or inadequate mechanics of
ventilation (residual muscle relaxation). The direct physiologic effect
of hypercarbia is peripheral vasodilation. Indirectly, hypercarbia stimulates
the sympathetic nervous system via the vasomotor center to increase myocardial
contractility, heart rate, stroke volume, and blood pressure. The vigor
of these responses is reduced by anesthesia.

Hypoxemia plus hypercarbia is extremely dangerous because
acidosis (respiratory) potentiates the depressant effects of hypoxemia
on myocardium and brain, and leads to bradycardia and cardiac arrest. Even
with successful cardiac resuscitation, brain damage often results. To maintain
oxygen transfer, more than oxygen content is required. A high enough PaO2
is needed to get oxygen into cells.

As soon as hypoxemia develops, anaerobic metabolism is
utilized by cells to produce energy, a very inefficient method. Depending
on the severity and duration of hypoxemia, vital functions fail. Thus,
brain function diminishes, manifested by disorientation, obtundation, and
coma; myocardial dysfunction reduces contractility, heart rate, blood pressure,
and stroke volume and often leads to arrhythmias. Other organ functions
deteriorate, though at a slower pace. Unlike in the unanesthetized situation
when hypoxemia stimulates the vasomotor center via the carotid body chemoreflex
to increase cardiac function, this mechanism is almost never operative
when residual anesthesia let alone surgical levels of anesthesia are present.
Of equal importance, the vigorous respiratory response to hypoxemia seen
in unanesthetized intact preparations is essentially abolished by either
narcotics or inhalation anesthetics. This can result in further hypoventillation,
hypoxemia, and cardiac and/or respiratory arrest within minutes.

Thus, in answer to the question: Is monitoring for hypoxemia
more important than for hypercarbia?, the answer is a qualified yes. Hypercarbia,
if due to hypoventillation leads to hypoxemia, which in all cases from
whatever cause, must be detected to initiate corrective therapy and prevent
anesthesia related disasters.

Improved patient safety! Such a noble goal rnust be in
the very heart of every conscientious anesthesiologist-but how? It is only
by knowing where the problems are that any concerted effort can be made
to master them, and therein hangs the major obstacle to beginning the attack

The American Society of Anesthesiologists has initiated
a massive review of closed claims against anesthesiologists, as found in
the files of IS of the physician-owned insurance companies and of the St.
Paul Fire and Marine Company. Acting through its Professional Liability
Committee, chaired by Frederick W. Cheney, Jr., M.D., a practicing anesthesiologist
will review each dosed claim in the individual state's files, extracting
the data of importance to the clinician. The data will be collated by Richard
J. Ward, M.D., a member of the Committee, and used by the Society in its
many teaching activities

This project, like so many dynamic ones, had its start
in the minds of several persons, whom chance brought together at the auspicious
moment. An attorney friend (later the wife) of Richard Solazzi, M.D., suggested
that considerable data on anesthetic malpractice problems could be found
in the files of the insurance companies. Dr. Solazzi, then a resident in
Anesthesiology at the University of Washington, suggested to Dr. Ward that
they review the files of the Aetna Insurance Company to ascertain which
clinical problems led to malpractice suits. The two reviewed a decade's
experience in Washington State in the files of the Aetna Insurance Company,
of the King County Medical Examiner, and of the two largest hospital systems,
Group Health and the University of Washington. At the same time on the
opposite coast, Ellison C. Pierce, Jr., M.D., was editing a book on anesthesia
mishaps. The Washington state data was included in the book, but much more
importantly, stirred the officers of the ASA to pursue a national survey,
large enough to identify the common and not so common clinical problems
that caused patient injury

Changes in the insurance coverage suggested that it would
be best to approach the physician-owned insurance companies, and the St.
Paul fire and Marine Company. The cooperation of the insurance companies
has been outstanding, as it was with the Aetna Insurance Company in the
original survey. To date 432 cases have been reviewed, and a preliminary
estimate suggests that over 1000 may be available for review when the program
is finished.

The program is unique in several ways. It is, by far,
the largest review of anesthesia complications, and the resultant

malpractice suits, in America. Secondly, by having practicing
anesthesiologists do the reviewing, it allows professional judgments to
be made about many of the aspects of clinical care. Judgments are being
made in several areas, such as: was the recorded preanesthesia evaluation
adequate, would better preanesthetic evaluation probably have prevented
the complications, would currently available monitors have prevented the
complication (even though they were not available at the time of the complication),
was the anesthesia care adequate or inadequate, could the anesthetic have
caused the complication, was the treatment adequate if there was a cardiac
arrest, and who was responsible for the complication (even though not preventable).

These professional judgments offer unique strength to
the survey, and allow it to go far beyond the usual survey details, i.e.,
general or regional anesthesia administered, the type of complication noted,
and the cost of any judgment. The identification of both preventable and
non-preventable complications, and their causes, point the way to the proper
targets of the ASA's educational programs for physicians. These targets
have, to date, remained elusive, but they are now being identified.

As an example, of the 432 suits reviewed there were 29
patients who had an unrecognized esophageal intubation that caused the
patient to die or have brain damage. Eighteen of these patients had bilateral
auscultation of the chest. While it was surprising to note the comparatively
high frequency of this complication, it was much more so to note that bilateral
auscultation of the chest so frequently failed in making the diagnosis.

The efficacy of pulse oximetry and end tidal carbon dioxide
analysis has been demonstrated in the findings to date. In a subset of
156 cases, it was estimated that these monitors, especially pulse oximetry,
would have prevented 20% of the complications. This 20% represented almost
60% of the payments, $13,000,000 of the total of $24,000,000.

The costs of inadequate care are equally well demonstrated.
'Mere is no way that we can quantify the depth of the personal tragedy
of severe complications or death, but we can quantify the dollar costs.
The average settlement when the care was adjudged adequate was $88,597,
while it jumped to $220,953 when the care was considered to be inadequate.

The primary goal of the study is to improve patient safety,
by identifying the complications that occur during routine clinical anesthesia,
and then developing study programs to communicate the findings to the clinicians.
Recognizing that the study group may be a skewed population (although a
growing number of complications seem to be followed by a suit), two derivative
studies are being contemplated. Working with the Society of Academic Anesthesia
Chairmen, a parallel study may be made compiling the clinical complications
reported in the weekly mortality and morbidity conferences of a large number
of training programs. The other would be a compilation of the data available
from anesthetic deaths reviewed by participating medical examiners of the
country. Almost half of the medical examiners said that they reviewed all
or most of the anesthetic deaths reported to them. further, they feel that
they hear about most of the anesthetic deaths in their comrnunity. These
facts came from a survey of the members of the National Association of
Medical Examiners by Drs. Richard J. Ward and Donald Reay, the King County,
Washington, Medical Exarniner. Thus, a large number of anesthetic deaths
are already being reviewed by the medical examiners, and a national survey
of these could, and should, be made.

Data are being shared with the participating insurance
companies who request it, and they will likewise work on improving patient
safety in ways that they find most effective.

Dr. Ward is Professor of anesthesia, University of Washington
School of Medicine, Seattle.

The fifth and sixth ASA Patient Safety videotapes, Human
Error and Adverse Events, were filmed in December and are now being mailed.
Earlier tapes in the series included, Overview, Prevention of Disconnections,
Anesthesia Machine Check-Out, and Anesthesia Record-Keeping.

Human Error considers data from several studies here and
abroad that examine why humans err and what preventive steps may be taken.
Drs. Howard L. Zauder, Harry H. Bird, Susan E. Dorsch, William K. Hamilton
and Maxwell H. Weingarten present in-depth reviews of various aspects of
the problem in the 20-minute segment that was taped at the Bethesda Naval
Hospital. Dr. Honorato F. Nicodemus, Chairman of Anesthesia at the hospital,
his staff, and the operating room personnel were extraordinarily cooperative
in aiding production.

Adverse Events In Anesthesia, filmed in the FDA studios,
thoroughly examines the necessary steps involved in pre-, intra-, and post-operative
management of patients undergoing anesthesia that will provide the best
possible care for a patient when an adverse event does occur. In addition,
it outlines the role these steps provide in lessening the likelihood of
medical liability proceedings.

The patient safety videotape series is being received
with enthusiasm in many quarters, especially including individuals in U.S.
congressional staff offices, hospital risk management, and the medical
liability insurance industry. In addition, arrangements are under way for
its sale in Great Britain. Seventh and eighth tapes on functions and mechanisms
of actions of monitoring are being planned.

The Anesthesia Patient Safety Foundation Newsletter is
the official publication of the non-profit Anesthesia Patient Safety Foundation
and is published quarterly in March, June, September, and December at Overland
Park, Kansas. All contributions to the Foundation are tax deductible.

The opinions expressed in this newsletter are not necessarily
those of the Anesthesia Patient Safety Foundation or its members or board
of directors.